External breast prostheses are artificial breast forms that can be worn after a surgery or other treatment in which the breast has been altered or removed. For example, external breast prostheses are available for women who have had a mastectomy or lumpectomy to remove a breast cancer, and to those who have uneven or unequal sized breasts resulting from radiation or reconstruction procedures.
A mastectomy is a common treatment for breast cancer that involves surgically removing the breast or a portion of the breast. A modified radical mastectomy is the most common type of mastectomy performed today. This procedure involves removing the breast, nipple/areolar region, and often the axillary (underarm) lymph nodes. Other types of mastectomies include simple mastectomy which generally involves removing the breast but no lymph nodes, and partial mastectomy which generally involves removing a cancerous or otherwise abnormal portion of the breast tissue along with a margin of normal breast tissue.
An external breast prosthesis can be worn to help replace the appearance and feel of a breast removed or altered by surgery. Such replacement is often not only for cosmetic, psychological and emotional reasons, but also can provide physiological benefits as well. For example, some breast prostheses are weighted as a therapeutic measure to replace the weight of the lost breast. When fitted with a breast prosthesis that approximates the size and weight of the remaining breast, the weight equilibrium of the body may be kept in balance following surgery to help avoid musculoskeletal problems such as lower back and neck pain which are common following a mastectomy.
Currently available external breast prostheses include entire breast forms and partial forms. Partial breast prostheses are commonly known as equalizers. Breast prostheses can be symmetrical (i.e., they can be turned to fit either side of the body) or asymmetrical (i.e., they fit only the right or the left side). Prostheses can be attached to the skin using an adhesive or other attachment mechanism. Alternatively, a breast prosthesis may be worn inside of a garment such as a mastectomy bra which includes a pocket or other feature to hold the prosthesis in place. Prefabricated prostheses can come in various shapes, sizes and skin tones and may be custom fabricated using a mold that is taken of the breast and/or chest wall prior to or after surgery.
Most external breast prostheses available today are made of a gel, either silicone or water based, contained in a plastic film that acts as a skin to contain the gel. The film is generally made of polyurethane and is substantially inelastic. Existing external breast prostheses incorporating such plastic film have a number of drawbacks and deficiencies. For example, the film has an unnatural, relatively inflexible feel that is substantially different to the touch from the feel of human skin. Also, the film forms hundreds of wrinkles as the prosthesis is deformed from its original molded shape. In fact wrinkles generally are always present on the prosthesis skin even when such prosthesis is donned. Also, the inner gel used in such a prosthesis must have its own shape, as the film does not have the inherent ability to force the gel into a predetermined shape.
Other available external breast prostheses consist of a piece of foam in the shape of a human breast. Such foam prostheses generally lack the consistency, feel, appearance and weight of gel-filled prostheses and are therefore of limited functionality and performance. In some cases, such prostheses are used temporarily following surgery, for example to provide a basic breast form that is light-weight to minimize discomfort during healing of the surgical scars.
Some existing breast prostheses have two or more chambers defined by polyurethane films, where each chamber is filled with a gel of different consistency or firmness. Like existing single-chambered prostheses, such multi-chambered prostheses employ a thin polyurethane outer barrier that is substantially inelastic and lacking characteristics that provide the look and feel of human skin.
Accordingly, there is a need in the art to provide improved external breast prostheses having the texture, appearance, and elasticity of a normal human breast.